"FDA迅速通過太景生技的肺炎藥物"

太景生技宣布美國食品藥品監督管理局（FDA）決定給予他們的奈諾沙星藥品「快速通關」的待遇，奈諾沙星使用於治療肺炎和皮膚感染。

太景生技的副總經理邵榮凱表示，奈諾沙星能獲快速研發批准是因為美國市場中此種藥物的需求仍未滿足。一旦經核准，太景生技和合夥人將獲得販售奈諾沙星的獨家權利，效期長達十年。此藥品的專利至2029年都有效，而此權利將由美國政府發放，應能提供太景生技額外的保障，保護他們不受其他公司的專利威脅，並確保他們在市場中成功。

此種藥品已經通過了第二階段的藥物測試，並且要走向第三階段，邵榮凱表示該公司現在正在尋找購買此藥品的企業。邵榮凱也表示：「能夠『快速通關』將能讓我們跟美國食品藥品監督管理局的官員更加頻繁地見面，讓我們能夠提供他們必要的數據並且在短時間內達到他們的要求。」然而，FDA尚未給出確切的核准日期。

太景生技公佈從一月到上個月底的營收為6335萬新台幣。這個數據跟去年相比提升了84.51%。

(Business) FDA Fast-Tracks TaiGen Pneumonia Medicine

TaiGen Biotechnology Co announced the decision by the US Food and Drug Administration (FDA) to fast-track the development of their drug nemonoxacin, used to treat pneumonia and skin infections.

TaiGen Vice President Peter Tsao stated that the drugs approval was being pushed ahead as the American market for such a drug remains unmet, and that once approved, TaiGen and its partners will receive exclusive rights to sell the drug for ten years. The drug patent, which lasts until 2029, and the rights granted by the American government, should provide extra protection against patent challenges by other companies and ensure their success in the market.

The drug has already passed the second phase of drug trials and moved onto phase three, with Tsao stating that the company is now is looking for firms to purchase the drug. Tsao also stated, Being on the fast track will allow us to meet with officials from the US Food and Drug Administration more frequently, allowing us to provide them with necessary data and meet their requirements within a shorter period of time. However, the exact date of approval has not been given.

TaiGen reported revenues of NT$63.35 million from January to the end of last month. This figure is up 84.51 percent from a year ago.

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